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Virtual Reality Analgesia in Labor: The VRAIL Pilot Study (VRAIL)

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ClinicalTrials.gov Identifier: NCT02926469
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Melissa Bauer, University of Michigan

Brief Summary:
The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual Reality (VR) during labor. We will also explore whether VR distraction is helpful for reducing subjective pain during labor, even if this pain is severe or excruciating. We predict that VR is feasible in this setting and that VR distraction will reduce acute pain and anxiety during labor.

Condition or disease Intervention/treatment Phase
Labor Pain Device: Virtual Reality Not Applicable

Detailed Description:
This study used an over the counter consumer product to create a virtual reality experience so that we could assess whether there was a decrease in perception of pain.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
Actual Study Start Date : October 25, 2016
Actual Primary Completion Date : April 14, 2017
Actual Study Completion Date : April 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Standard Care
For patients presenting in labor and desiring standard care (natural childbirth without pain medications, systematic distraction, or alternative therapies) the patient will experience their contractions. Afterwards they will answer pain and anxiety questionnaires.
Experimental: Virtual Reality
For patients presenting in labor and desiring standard care (natural childbirth without pain medications, systematic distraction, or alternative therapies) the patient will experience their contractions while using immersive Virtual Reality.Afterwards they will answer pain and anxiety questionnaires.
Device: Virtual Reality
Using Virtual Reality during labor




Primary Outcome Measures :
  1. Pain and Anxiety [ Time Frame: one time for the duration of one minute after 10 minutes of contractions with standard care ]
    Pain is measured one time after 10 minutes of contractions with standard care, by asking the subjects about their pain and anxiety level, using a questionnaire called graphic rating scale.

  2. Pain and Anxiety [ Time Frame: one time for the duration of one minute after 10 minutes of contractions using Virtual Reality ]
    Pain is measured one time after 10 minutes of contractions with Virtual Reality, by asking the subjects about their pain and anxiety level, using a questionnaire called graphic rating scale.

  3. Satisfaction [ Time Frame: one time for the duration of one minute after using Virtual Reality ]
    Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any woman giving birth for the first time at or after 32 weeks
  • Low risk pregnancy without obstetric complications
  • In first stage of labor for vaginal delivery
  • Desires non-pharmacologic alternative for pain control

Exclusion Criteria:

  • Younger than 18 or older than 45 years of age
  • Presence of fetal or placental anomaly
  • High risk pregnancy or anesthetic concerns (BMI>40, difficult airway, hemorrhage, nonreassuring FHR, malpresentation)
  • Current use of pharmacologic analgesia including neuraxial anesthesia
  • Not capable of answering study measures using numeric rating scale
  • Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
  • Any form of contact precautions
  • Severe hearing or vision deficits
  • Susceptibility to motion sickness
  • Seizure history
  • History of psychiatric disorder, chronic pain, migraines, or addiction
  • Delirium, psychosis, any form of developmental delay, or Organic Brain Disorder
  • Requiring an interpreter for communication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926469


Locations
United States, Michigan
University of Michigan Von Voigtlander Women's Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Melissa Bauer, DO University of Michigan

Responsible Party: Melissa Bauer, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02926469     History of Changes
Other Study ID Numbers: HUM00116129
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melissa Bauer, University of Michigan:
Virtual Reality
Analgesia
Immersive Virtual Reality
VR
Labor
Pain

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms